Transcript Sentinel Events and Medical Errors

Medical Errors,
Sentinel Events, and
Accreditation
Association of Anesthesia Program Directors
October 28, 2000
Joint Commission
on Accreditation of Healthcare Organizations
1
“Mistakes are at the very base of human thought,
embedded there, feeding the structure like root nodules. If we
were not provided with the knack of being wrong, we could
never get anything useful done.”
“We are built to make mistakes, coded for error …
The capacity to leap across mountains of information and
land lightly on the wrong side represents the highest of
human endowments.”
Lewis Thomas, 1974
Joint Commission
on Accreditation of Healthcare Organizations
2
Accreditation is,
at its core,
a risk reduction activity.
Joint Commission
on Accreditation of Healthcare Organizations
3
The Joint Commission’s
Sentinel Event Policy

Established in January 1996 with the following goals:

To have a positive impact in improving care

To focus attention on underlying causes and risk
reduction

To increase the general knowledge about sentinel
events, their causes and prevention

To maintain public confidence in the accreditation
process
Joint Commission
on Accreditation of Healthcare Organizations
4
Sentinel Event
A sentinel event is an unexpected occurrence
involving death or serious physical or
psychological injury, or the risk thereof.
Serious injury specifically includes the loss of
limb or function.
The phrase, "or the risk thereof" includes
any process variation for which a recurrence
would carry a significant chance of a serious
adverse outcome.
Joint Commission
on Accreditation of Healthcare Organizations
5
To Err Is Human:
Building a Safer Health System
Institute of Medicine Report, November 1999

44,000 – 98,000 patient deaths annually due to error

Goal: 50% reduction in errors over the next 5 years

Recommendations:
 National Center for Patient Safety within DHHS
 Mandatory reporting to state agencies
 Engage consumers, purchasers, accreditors,
regulators
 Effect a culture shift to make safety a top priority
Joint Commission
on Accreditation of Healthcare Organizations
6
Joint Commission Public Policy Position on
Reporting & Managing Medical Errors

In order to measurably improve patient safety, the Joint
Commission supports

Creation of an effective national reporting system
(mandatory or voluntary)

Conditioned on the following:
1.
2.
3.
4.
5.
6.
Limited to well-defined “serious adverse events,” if mandatory
Standardized definition of a reportable medical error or event
Requirement for in-depth analysis of each error/event
Federal protection from disclosure of the resulting information
Requirement for action plan with follow-up
Sharing of event-related information with oversight bodies
Joint Commission
on Accreditation of Healthcare Organizations
7
Experience to Date
Of 983 sentinel events reviewed by the
Accreditation Committee:
188
126
119
88
51
49
42
41
32
22
22
18
18
167
inpatient suicides
events relating to medication errors
operative/post op complications
events of surgery at the wrong site
deaths related to delay in treatment
patient falls (13 multi-story)
assault/rape/homicide
deaths of patients in restraints
deaths following elopement
transfusion-related events
Perinatal death/injury
infant abductions/wrong discharges
fires
“other”
Joint Commission
on Accreditation of Healthcare Organizations
8
Total “Reviewed” Events by State
8
6
9
2
4
56
29
31
5
32
10
7
2
62
14
1
3
5
59
9
6
6
7
30
55 11
5
14
8
9
13
8 25
24
20
17
43
5
15
9
10
16
9
8
68
34
22
International
3
8
62
3
2
PR: 13
Joint Commission
on Accreditation of Healthcare Organizations
9
Sources of Sentinel Event Information
Self-report
Media
Other
350
300
250
200
150
100
50
0
1995
1996
1997
1998
Joint Commission
on Accreditation of Healthcare Organizations
1999
2000
10
Settings of the Sentinel Events
Total events
General hospital
Psychiatric hospital
Psychiatric unit
Out-pt behavioral health
Long term care facility
Emergency department
Home care service
Ambulatory care setting
Clinical laboratory
Health care network
0
200
400
600
Joint Commission
on Accreditation of Healthcare Organizations
800
1000
1200
11
Root cause analysis …
. . . a process for identifying the
basic or causal factors that underlie
variation in performance, including
the occurrence or possible
occurrence of a sentinel event.
Joint Commission
on Accreditation of Healthcare Organizations
12
Classification of Root Causes

General classification based on
Joint Commission standards

Patient care functions

Organization management
functions
Joint Commission
on Accreditation of Healthcare Organizations
13
Root Causes of Sentinel Events
(All categories)
Orientation/training
HR.4
Communication
LD.3.2 / IM.5
Pt. Assessment process
PE.1
Physical environment
EC
Information availability
IM.5
HR.5/MS.5
Competency/credentialing
Equipment factors
EC.2.7/EC.2.13
HR.2
Staffing levels
Storage/access
TX.3.5/TX.4.3/EC.4.1
0
10
20
30
40
50
60
70
Percent of events
Joint Commission
on Accreditation of Healthcare Organizations
14
Root Causes of Medication Errors
Orientation/training
HR.4
Communication
LD.3.2 / IM.5
Storage/access
TX.3.3/3.5
IM.5
Information availability
Competency/credentialing
HR.5/MS.5
Supervision
MS.2.5
Labeling
TX.3.5
Distraction
EC.4.1
0
10
20
30
40
50
60
70
Percent of events
Joint Commission
on Accreditation of Healthcare Organizations
15
Root Causes of Wrong Site Surgery
IM.5
OR team miscommunication
Incomplete pt assessment
PE.1.8
Verification Policy not followed
?
OR hierarchy
?
No communication with pt
TX.5.2/PF.1.10
No verification process
?
IM.5
Info not available in OR
EC.4.1
Distraction
HR.5 / MS.5
Competency / credentialing
0
10
20
30
40
50
60
70
80
Percent of events
Joint Commission
on Accreditation of Healthcare Organizations
16
Strategies for Reducing the Risk
of Wrong Site Surgery
Mark operative site
Require verbal team verification in OR
Develop verification checklist
Require surgeon to get informed consent
Require pre-op site verification by patient
Software enhancements
Revise competency assessment process
Monitor high-risk policy compliance
Percent of events
Revise equipment set-up procedures
0
10
20
30
Joint Commission
on Accreditation of Healthcare Organizations
40
50
60
70
80
17
Suggestions from the Joint Commission to
Reduce the Risk of Wrong-Site Surgery:
1. Involve patient and surgeon in pre-op
identification and marking of operative site
2. Implement verbal verification process in O.R.
Other strategies that may be helpful:
 Personal involvement of the surgeon in
obtaining informed consent
 Ongoing monitoring of compliance with highrisk procedures (e.g., site verification
procedure)
 Software enhancements to ensure consistent
site identification and information availability
Joint Commission
on Accreditation of Healthcare Organizations
18
SENTINEL EVENT ALERT
A publication of the Joint Commission on
Accreditation of Healthcare Organizations
Issue One
2-27-98
Joint Commission
on Ac c reditation of H ealthc are Organiz ations
One Renaissance Boulevard
Oakbrook Terrace, IL 60181
Phone: (630) 792-5800
New Publication
"The way to prevent
tragic deaths from
accidental intravenous
injection of concentrated
KCl is excruciatingly
simple - -organizations
must take it off the floor
stock of all units. It is
one of the best
examples I know of a
'forcing function' -- a
procedure that makes a
certain type of error
impossible."
Lucian L. Leape, M.D.
We are pleased to introduce the first issue of Sentinel Event Alert, a
periodic publication dedicated to providing important information relating to
the occurrence and management of sentinel events in Joint
Commission-accredited health care organizations. Sentinel Event Alert, to
be published when appropriate as suggested by trend data, will provide
ongoing communication regarding the Joint Commission's Sentinel Event
Policy and Procedures, and most importantly, information about sentinel
event prevention. It is our expectation and belief that in sharing information
about the occurrence of sentinel events, we can ultimately reduce the
frequency of medical errors and other adverse events.
Medication Error Prevention -- Potassium Chloride
In the two years since the Joint Commission enacted its Sentinel Event
Policy, the Accreditation Committee of the Board of Commissioners has
reviewed more than 200 sentinel events. The most common category of
sentinel events was medication errors, and of those, the most frequently
implicated drug was potassium chloride (KCl). The Joint Commission has
reviewed 10 incidents of patient death resulting from misadministration of
Joint Commission
on Accreditation of Healthcare Organizations
19
Sentinel Event Trends:
All Reviewed Events
500
400
300
200
100
0
1995
1996
1997
1998
Joint Commission
on Accreditation of Healthcare Organizations
1999
2000
20
Sentinel Event Trends:
Potassium Chloride Events
10
S. E. Alert # 1
February 1998
8
6
4
2
0
1995
1996
1997
1998
Joint Commission
on Accreditation of Healthcare Organizations
1999
2000
21
Sentinel Event Trends:
Suicide Events (Percent of Total)
30
S. E. Alert # 7
November 1998
25
20
15
10
5
0
1995
1996
1997
1998
Joint Commission
on Accreditation of Healthcare Organizations
1999
2000
22
Sentinel Event Trends:
Restraint Deaths (Percent of Total)
10
S. E. Alert # 8
November 1998
8
6
4
2
0
1995
1996
1997
1998
Joint Commission
on Accreditation of Healthcare Organizations
1999
2000
23
Sentinel Event Trends:
Wrong-site Surgery (Percent of Total)
16
S. E. Alert # 6
14
August 1998
12
10
8
6
4
2
0
1995
1996
1997
1998
Joint Commission
on Accreditation of Healthcare Organizations
1999
2000
24
Proactive Risk Reduction

RCA is reactive; subject to “hindsight bias”

The sentinel event can have a “blinder” effect


The best RCAs look at all the risk points
Why wait for the sentinel event?
 Identify the high risk processes
 Conduct proactive risk assessment
 Redesign for safety
Joint Commission
on Accreditation of Healthcare Organizations
25
IOM Recommendation for
Establishment of Safety Programs

Health care organizations should establish patient
safety programs with defined executive responsibility
that




are clearly focused on patient safety,
implement non-punitive systems for reporting and
analyzing medical errors,
incorporate well-understood safety principles, and
establish interdisciplinary team training for
providers of patient care which incorporates
proven methods of team training.
Joint Commission
on Accreditation of Healthcare Organizations
26
Government’s Response
to the IOM Report

The President’s response

The QuIC Report

HCFA’s response
 New Condition of Participation establishing
requirement for Patient Safety Programs in
hospitals
Joint Commission
on Accreditation of Healthcare Organizations
27
Standards Relating
to Sentinel Events
LD.4.3.4
Role of Leadership
PI.2
Design of new processes
PI.3.1.1
Data collection
PI.4.3
Root cause analysis
PI.4.4
Action plan
Joint Commission
on Accreditation of Healthcare Organizations
28
Proposed Revisions to Joint Commission
Standards in Support of Error Reduction
Programs in Health Care Organizations

Leadership

Performance Improvement

Information Management

Other functions
Joint Commission
on Accreditation of Healthcare Organizations
29
Proposed Standards Revisions
for Error Reduction Programs

Leadership standards to emphasize safety

In response to actual occurrences

As a component of new design and redesign
activities

As an ongoing proactive effort.
Joint Commission
on Accreditation of Healthcare Organizations
30
Proposed Standards Revisions
for Error Reduction Programs

Performance Improvement standards to require

Proactive risk assessment and risk reduction

. . . Based on available risk-related information

Focused on high-risk activities selected by the
organization.
Joint Commission
on Accreditation of Healthcare Organizations
31
Proposed Standards Revisions
for Error Reduction Programs

Information Management standards to strengthen

Aggregation of safety-related information

Use of knowledge-based information on safetyrelated issues

Effective communication among participants in
health care processes
Joint Commission
on Accreditation of Healthcare Organizations
32
Proposed Standards Revisions
for Error Reduction Programs

Other standards-based functions, including

Patient Rights

Patient and Family Education

Continuum of Care

Environment of Care

Human Resource Management
Joint Commission
on Accreditation of Healthcare Organizations
33
Joint Commission Standards
Are designed to . . .

Focus on safety and quality of patient care

Represent consensus on state-of-the-art in
expected organization performance

Whenever possible, be evidence-based

State objectives or principles, rather than specific
mechanisms for meeting requirements

Be reasonable and achievable

Be surveyable
Joint Commission
on Accreditation of Healthcare Organizations
34
Standards Development Process









Ongoing field analysis and literature review
Preliminary review by Professional & Technical
Advisory Committees (PTACs)
Internal & external workgroups
Qualified experts in the relevant fields
Field evaluation of draft standards
Further revision based on field evaluation
Review by PTACs
Approval by SSP Committee of the Board
Ongoing field assessment (compliance monitoring)
Joint Commission
on Accreditation of Healthcare Organizations
35
Standards Relevant to
Anesthesia Services









Patient rights
Patient assessment
Anesthesia care
Medication use
Leadership
Performance improvement
Human resources management
Information management
Medical staff
Joint Commission
on Accreditation of Healthcare Organizations
36
Sedation and Anesthesia Defined
1. Minimal sedation
 Cognitive function & coordination affected
 Respond normally to verbal commands
 CP function unaffected
2. Moderate sedation / analgesia (“conscious sedation”)
 Drug-induced depression of consciousness
 Purposeful response to verbal stimuli
 Adequate spontaneous ventilation
 Cardiovascular function maintained
Joint Commission
on Accreditation of Healthcare Organizations
37
Sedation and Anesthesia Defined
3. Deep sedation / analgesia
 Drug-induced depression of consciousness
 Cannot be easily aroused
 Purposeful response to painful stimuli
 Airway / ventilation may be impaired
 Cardiovascular function ususally maintained
4. Anesthesia
 General anesthesia
 Spinal anesthesia
 Major regional anesthesia
Joint Commission
on Accreditation of Healthcare Organizations
38
Standards Relevant to
Anesthesia Services









Patient rights
Revised to apply to Moderate
Patient assessment
and Deep Sedation and
Anesthesia care
Anesthesia
Medication use
Effective January 2001
Leadership
Performance improvement
Human resources management
Information management
Medical staff
Joint Commission
on Accreditation of Healthcare Organizations
39
Patient Rights

Informed consent

Clear explanation of proposed treatments
 Potential benefits and drawbacks
 Likelihood of success
 Alternatives, including non-treatment
 Possible results of alternatives or non-treatment
 Possible need for and risks of transfusion
 Identity/professional status of practitioners

These are process requirements, not
documentation requirements
Joint Commission
on Accreditation of Healthcare Organizations
40
Patient Assessment

Pre-anesthesia assessment






All moderate or deep sedation or anesthesia
Assess risk & select form of sedation/anesthesia
Determine patient is an appropriate candidate
Qualified L.I.P. conducts or confirms
Re-evaluate immediately pre-induction
Post-anesthesia assessment


On admission to, during, & discharge from PACU
Discharge by L.I.P. or approved criteria
Joint Commission
on Accreditation of Healthcare Organizations
41
Anesthesia Care

Sedation / anesthesia care is planned



The need for blood / components is considered
The plan is communicated among the care
providers
The patient’s physiologic status is monitored





Heart & respiratory rate
Oxygenation (continuous pulse oximetry)
Adequacy of pulmonary ventilation
BP at regular intervals
ECG if known CV disease or dysrhythmias
Joint Commission
on Accreditation of Healthcare Organizations
42
Medication Use

Medications are appropriately controlled

Emergency medications are consistently
available, controlled, and secure

Does not require anesthesia carts to be locked

Does not require constant attendance if
1. They are in a limited access area
2. No evidence of abuse, misuse, or diversion
Joint Commission
on Accreditation of Healthcare Organizations
43
Leadership

Uniform performance


Consistency of process for sedation / anesthesia
procedures for comparable risk patients in
different locations
 Assessment
 Monitoring
 Recovery & discharge
Department directors’ responsibilities
Joint Commission
on Accreditation of Healthcare Organizations
44
Department Directors’ Responsibilities











All clinical activities within the department
Integrate and coordinate
Policies and procedures
Recommend staffing levels
Determine qualifications & competence of staff
Surveillance of professional performance of L.I.P.s
Involve department in performance improvement
Maintain quality control programs
Provide for orientation, continuing education
Recommend space and other resources
Participate in selecting outside vendors
Joint Commission
on Accreditation of Healthcare Organizations
45
Improving Organization Performance

Department vs. organization-wide requirements

Required measurement & analysis:
 Significant adverse events associated with
anesthesia use
 Outcomes of patients undergoing moderate and
deep sedation
 Outcomes related to resuscitation
 Patient perceptions of pain management
 Confirmed transfusion reactions
 Significant adverse drug reactions
 Significant medication errors
 All sentinel events
Joint Commission
on Accreditation of Healthcare Organizations
46
Information Management

Required documentation in the medical
record:







Informed consent, when req’d by the hospital
Findings of patient assessments
Clinical observations
Response to care, including sedation / anesth.
All medications administered
Any adverse drug reactions
Discharge from PACU
 Compliance with discharge criteria
 Responsible L.I.P.
Joint Commission
on Accreditation of Healthcare Organizations
47
Human Resources Management




Sufficient numbers of qualified personnel (in addition
to the L.I.P. performing the procedure)
 To evaluate the patient prior to sedation / anesth.
 To provide the sedation / anesthesia
 To perform the procedure
 To monitor the patient
 To recover and discharge the patient
Staffing plan
Orientation & training
Competency assessment
Joint Commission
on Accreditation of Healthcare Organizations
48
Medical Staff Credentialing

Qualified individuals provide sedation / anesthesia

Licensed independent practitioners (L.I.P.s)

Competent to

evaluate patients for sedation / anesthesia

administer drugs to predictably achieve
desired level of sedation / anesthesia

monitor patients to maintain desired level

rescue patients who have slipped into next
level of sedation / anesthesia
Joint Commission
on Accreditation of Healthcare Organizations
49
Survey Process

Anesthetizing locations visits






Operating room
Same-day surgery
Endoscopy suites
Interventional radiology / special procedures
Dental clinics . . .
Scheduled visits
 Interact with direct care staff
 Evaluate compliance with relevant standards
 Observe patients in PACU
 Physical environment, equipment & utilities mgmt.
Joint Commission
on Accreditation of Healthcare Organizations
50
Survey Process

Patient Care Interview





Builds on earlier survey activities
Brings together representatives of staff concerned
with all aspects of patient care
Assesses coordination of care
Addresses unresolved issues
Medical Staff Leadership Interview


Includes department directors
Assesses MS role in hospital activities relating to
patient care and performance improvement
Joint Commission
on Accreditation of Healthcare Organizations
51
New Pain Assessment and
Management Standards
Effective January 1, 2001
Joint Commission
on Accreditation of Healthcare Organizations
52
What Do They Address?






Right to have Pain assessed and managed
Screening for and Assessment of Pain
Care
Education
Continuum of Care
Ongoing Organization Improvement
Joint Commission
on Accreditation of Healthcare Organizations
53
How Are They Surveyed?

Document Reviews
 Policy, Procedure, Practice Guidelines
 Minutes
 Open and Closed Patient Records

Observation and Interviews
 Staff
 Patients and Families
Joint Commission
on Accreditation of Healthcare Organizations
54
New Rights Standard

“All patients/individuals/residents/clients have
a right to have their pain assessed and
managed appropriately.”

Surveyors look for how you let recipients of
care and services know . . .
Joint Commission
on Accreditation of Healthcare Organizations
55
New Assessment Standard

Standard and its Intent Surveyed

“All patients/individuals/residents/clients
are assessed.”
All are Screened
Those with Pain are Assessed and Reassessed


Joint Commission
on Accreditation of Healthcare Organizations
56
Fifth Vital Sign?

“Yes” - for patients with pain found at time of
initial screening and/or for those who are likely
to have pain
 (e.g., surgery, sickle cell crisis)

Joint Commission standards do not view pain
assessments as fifth vital sign for all recipients
of care or services
Joint Commission
on Accreditation of Healthcare Organizations
57
Addition to Care Standards

Introduction
 Added “Symptom Management” to
Introduction

Medication Use
 Added “Patient-controlled Analgesia” to
medication administration standard as well
as “Epidural/Spinal and Other
Interventions” (complementary/alternative)
Joint Commission
on Accreditation of Healthcare Organizations
58
Many Ways to Provide “Pain Care”




Ambulatory, Home, Hospital, and Long Term Care
 Formal Pain Programs, Departments or Services
 Pain management included in Care Paths, Care
Maps, Clinical Practice Guidelines (CPGs), formal
Practice Parameters, Standards of Practice
 Enforced Standardized Protocols or Policy
Behavioral Health – Assessment Protocol or Policy,
Referral for individuals w/physical pain
Other Innovative Ways
Not Applicable for Health Care Networks, PPOs
Joint Commission
on Accreditation of Healthcare Organizations
59
New Education Standard

Patients/Individuals/Residents/Clients and their
families are educated about pain and managing
pain as part of treatment, when appropriate
(PF.3.4)

Intent of PF.3.4
 Understanding pain and the importance of
effective management
 Understanding cultural and belief system
barriers
Joint Commission
on Accreditation of Healthcare Organizations
60
New Continuum of Care Language

Addition to Intent of Discharge Planning standard
(CC.6.1)
 Discharge planning focuses on meeting
patients’ health care needs after discharge.
 Discharge planning identifies patients’
continuing physical, emotional, symptom
management (e.g., pain, nausea, or
dyspnea), housekeeping, transportation,
social, and other needs and arranges for
services to meet them.
Joint Commission
on Accreditation of Healthcare Organizations
61
PI.3.1 Collect Data

To monitor the organization’s performance
 Leaders prioritize data collection based on mission
and scope of services provided
 Leaders consider for data collection . . . The
appropriateness and effectiveness of pain
management
 Leaders required to collect data about the needs,
expectations, and satisfaction of individuals and
organizations served
Joint Commission
on Accreditation of Healthcare Organizations
62
Scoring PI.3 Data Collection

Surveyors will expect to see Evidence of data
collection on one or both topics

Outcomes of pain management (on consider list)

Results of Patient Perceptions related to
management of pain (on mandatory list)
Joint Commission
on Accreditation of Healthcare Organizations
63
In Summary . . .




Patient’s Rights Issue
Staff Competence Issue
 Screening, Assessment, Reassessment
 Appropriate Guidelines for Management
 Clinical Practice Guidelines
 Practice Parameters
Leadership Support, Policy/Procedure
Quality Monitoring for Improved Processes and
Outcomes
Joint Commission
on Accreditation of Healthcare Organizations
64